FDA cleared Emboline's Emboliner Embolic Protection System for use during transcatheter aortic valve replacement, the Santa Cruz, California company said September 9. The device is a dual-layer filter that spans the full width of the aorta and catches debris headed for the brain and the rest of the body.
Clearance rests on PROTECT H2H, a prospective, multicenter, randomized IDE study that put the Emboliner against Boston Scientific's Sentinel Cerebral Protection System. Emboline says the device met its primary safety and clinical performance endpoints and captured significantly more clinically relevant debris than the comparator. It has not released the enrollment count or the size of the difference.
The design difference is the commercial argument. Sentinel filters two of the three aortic arch vessels; the Emboliner runs the TAVR delivery system through a central lumen inside a filter that covers the whole vessel. Emboline raised more than $55M in a Series D to fund the study and plans a phased US launch later in 2026.
Running a randomized trial against the incumbent is an expensive way to support a 510(k), and it is most of the reason this one took years. It also leaves Emboline holding comparative data no competitor can cite.